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WASHINGTON -- The FDA today of olaparib (Lynparza) to include first-line treatment of patients with metastatic BRCA-positive breast cancer.

The approval made olaparib the first drug in the PARP inhibitor class with a breast cancer indication. The breast cancer indication follows approved indications for BRCA-positive ovarian cancer. Concurrently, the agency expanded approval of the companion diagnostic blood test BRACAnalysis CDx to include detection of BRCA mutations in patients with breast cancer.

"This drug has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer," Richard Pazdur, MD, of the FDA Office of Hematology and Oncology Products, said in a statement. "This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types."

Supporting evidence of the breast cancer indication came from a randomized trial of olaparib involving 302 patients with HER2-negative metastatic breast cancer associated with a germline BRCA mutation. The trial had a primary endpoint of progression-free survival (PFS), and the results showed that patients treated with olaparib plus chemotherapy had a median PFS of 7.0 months versus 4.4 months for patients who received only chemotherapy.

Common side effects associated with olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and oral stomatitis. Potential severe side effects of olaparib include myelodsplastic syndrome/acute myeloid leukemia and pneumonitis.

The FDA granted the olaparib approval to AstraZeneca Pharmaceuticals and the BRACAnalysis CDx approval to Myriad Genetics.

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